Care Coordination and Passive Mobile Data Monitoring to Improve Mental Health Care (CCM)

Care Coordination and Passive Mobile Data Monitoring to Engage Veterans and Improve Mental Health Care

Providing care to individuals with serious mental illness can be challenging, requiring ongoing monitoring, treatment adjustments, and coordination of various medical and social services. Rates of emergency service and hospital use are high due to unexpected social, medical, and mental health crises. Stressors and poor adherence with treatment are common and can lead to rapid worsening in symptoms, job loss, homelessness, incarceration, or suicide. Clinician visits can be infrequent. Patient-clinician contact between visits is challenging and often nonexistent. As such, illness exacerbations usually occur with no clinician awareness in real time, leaving limited opportunity to provide services. Clinicians need interventions that are capable of monitoring and quickly detecting worsening behaviors and illness, to improve care coordination, outreach, and treatment. This project studies the effectiveness of enhanced care coordination using passive mobile data monitoring and support from peer specialists, with the goal of improving outcomes and reducing the need for acute care.

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Mental Illness
• Intervention / Treatment: Behavioral: Care Coordination Mobile

Detailed Description

Overview: Providing care to individuals with serious mental illness (SMI) can be challenging, requiring ongoing monitoring, treatment adjustments, and coordination of various medical and social services. Rates of emergency service and hospital use are high due to unexpected social, medical, and mental health crises. A variety of stressors and poor adherence with treatment are common and can lead to rapid worsening in symptoms, job loss, homelessness, incarceration, or suicide. Clinician visits can be infrequent. Patient-clinician contact between visits is challenging and often nonexistent. As such, illness exacerbations usually occur with no clinician awareness in real time, leaving limited opportunity to provide services. This project studies, in Veterans with SMI and high risk for acute care, the effectiveness of an enhanced care coordination mobile intervention (CCM) that uses passive mobile data and support from peer coaches. The investigators hypothesize that CCM will reduce the need for acute care services in comparison to usual care.

Specific Aims:

Among Veterans with SMI:

1. Engage Veterans and clinicians in co-design activities that adapt previously tested protocols and tools to guide implementation of enhanced care coordination with mobile (CCM intervention) that includes passive mobile monitoring of Veterans' mental health status, technology and behavioral supports from peer coaches, and care coordination within a Behavioral Health Interdisciplinary Program (BHIP).
2. Determine the effectiveness of CCM on acute care use. Implement CCM using protocols and tools from Aim 1 and randomize high-risk patients with SMI to CCM or usual care for 9 months.
3. Evaluate implementation of CCM.
4. Conduct a budget impact analysis of CCM.

Methodology:

Population: patients with SMI and high risk for acute care use. Intervention: enhanced care coordination within a VA BHIP program using passive mobile monitoring and supports from peer coaches Comparison: effectiveness trial with randomization to CCM or usual care for 9 months Outcome: reduction in use of urgent care services (emergency visits, hospitalization, or death) Qualitative and quantitative methods

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander S Young, MD MSHS; Phone Number: (310) 268-3416; Email: Alexander.Young@va.gov
• Study Contact Backup: Name: Ronald Calderon, MSW; Phone Number: 46763 (310) 478-3711; Email: ronald.calderon@va.gov

Study Locations

• United States
  • California
    • West Los Angeles, California, United States, 90073-1003
      • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
      • Contact: Alexander S Young, MD MSHS; Phone Number: (310) 268-3416; Email: Alexander.Young@va.gov
      • Principal Investigator: Alexander Stehle Young, MD MSHS
      • Contact: Ronald Calderon, MSW; Phone Number: 46763 (310) 478-3711; Email: ronald.calderon@va.gov
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4551
      • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
      • Contact: Karina Montes; Phone Number: 215-823-6046; Email: Karina.Montesojeda@va.gov
      • Contact: David Oslin, MD; Phone Number: 2158235894; Email: Dave.Oslin@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• a medical record diagnosis of Serious Mental Illness (SMI)

  • defined as schizophrenia, schizoaffective disorder, or bipolar disorder
• receipt of care at the VA site during the prior 9 months
• a Care Assessment Need (CAN) score over the 75th percentile, indicating high risk for hospitalization or death in the upcoming year
• ownership of a smart phone

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CCM; Mobile monitoring, peer coaching, and enhanced care coordination	Behavioral: Care Coordination Mobile; Mobile monitoring, peer coaching, and enhanced care coordination; Other Names: CCM
No Intervention: usual care; Usual care services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute care utilization	Use of emergency service, use of hospitals, and death are each a binary measure (yes/no). These will be combined to make one binary measure that is yes if any one of these three is yes, and otherwise no.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interpersonal supports - Interpersonal Support Evaluation List (ISEL)	Level of social support measured using the Interpersonal Support Evaluation List-12 (ISEL). Scores can range from 0 to 36, with higher scores indicating a better outcome.	9 months
Patient activation - Patient Activation Measure (PAM)	Patient activation measured using the short-form Patient Activation Measure (PAM-13). Scores can range from 13 to 52, with higher scores indicating a better outcome.	9 months
Engagement with care - Working Alliance Inventory (WAI)	Engagement with care measured using the Working Alliance Inventory for General Practice (WAI-GP). Scores can range from 12 to 60, with higher scores indicating a better outcome.	9 months
Receipt of care appropriate for chronic conditions - Patient Assessment of Chronic Illness Care (PACIC)	Receipt of care appropriate for chronic conditions measured using the 20-item Patient Assessment of Chronic Illness Care (PACIC). Scores can range from 20 to 100, with higher scores indicating a better outcome.	9 months
Care experience - Ambulatory Care Experiences Survey (ACES)	Care experience measured using the Ambulatory Care Experiences Survey (ACES) Short Form. Scores can range from 0 to 100, with higher scores indicating a better outcome.	9 months
Psychiatric symptoms - Behavior And Symptom Identification Scale (BASIS-24)	Psychiatric symptoms measured using the Behavior And Symptom Identification Scale (BASIS-24). Scores can range from 0 to 96, with higher scores indicating worse outcomes.	9 months
Quality of life - Veterans RAND 12 item Health Survey (VR-12)	Health-related quality of life measured using the Veterans RAND 12 item Health Survey (VR-12). Scores can range from 0 to 100, with higher scores indicating a better outcome.	9 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Alexander Stehle Young, MD MSHS, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study record dates

Study Major Dates

• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Veterans; Health Care Utilization; Continuity of Patient Care; Disease Management; Mobile Applications; Patient Care Team; Peer Coaching; Mental Disorders, Severe; Remote Sensing Technology
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Mental Disorders; Patient Acceptance of Health Care
• Other Study ID Numbers: HSR4-022-24W

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Analytic datasets will be made available in accordance with local and national VA policy and compliance regulations. Mechanisms for sharing datasets will be based on infrastructure and resources available through either the local VA facility or VHA nationally. Researchers interested in accessing datasets will be required to sign a Data Use Agreement.

Preservation and sharing of analytic datasets will allow other researchers to replicate published results and/or perform additional analyses. Researchers will be provided with a limited dataset as well as documentation regarding methods used for dataset creation and analytic procedures.

• IPD Sharing Time Frame: Final datasets will be stored on the local secure VA Research server for the period required by the VA Records Control Schedule. Analytic datasets will be made available in accordance with local and national VA policy and compliance regulations.
• IPD Sharing Access Criteria: Mechanisms for sharing datasets will be based on infrastructure and resources available through either the local VA facility or VHA nationally. Researchers interested in accessing datasets will be required to sign a Data Use Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No